Senior Manager, CMC Regulatory Strategy

Job Title:   Senior Manager, CMC Regulatory Strategy

Division / Function:   Global Regulatory Affairs (GRA)

Main Responsibilities & Technical Competencies

• Work closely with Global Regulatory Affairs Therapeutic Area leads to integrate the CMC regulatory strategy to the overall regulatory strategy of all assigned projects.
• Define and execute the CMC regulatory strategy roadmaps for all products in scope (R&D and LCM) ensuring that regulatory requirements are met. Work closely with CMC regulatory senior management to ensure coherence of strategies across projects.
• Ensure regional regulatory specificities and needs are incorporated into the global plans incl. emerging regulations.
• Participate in gap/risk analysis activities as needed, prioritising and planning associated regulatory strategies to address any identified gaps/risks.
• Propose innovative CMC regulatory pathways to accelerate product delivery for patient.
• Communicate with global regulatory lead to propose de-risking through early communications with worldwide health authorities.
• Lead the CMC regulatory section preparation of briefing documents for regulatory positioning and justification in collaboration with the SMEs.
• Review of the Target Product Profile (TPP)/ Regulatory risk assessment/ Regulatory Strategy Document/ CCDS to ensure single aligned regulatory positioning and appropriateness of any CMC aspects, including pediatric (presentation, formulation, excipients) and ROW considerations.  
• Assess CMC-Regulatory impact of all changes proposed to the allocated product portfolio, providing strategic regulatory advice and clearly communicating any Regulatory impact and CMC-Regulatory supporting data requirements for subsequent variations.
• Contribute to the development and maintenance of efficient, compliant and robust systems, procedures and processes.
• Manage all Regulatory interactions for Site Registrations, Site Licences, and site accreditations with Regulatory Authorities, Alliance partners and CMO’s for assigned product(s) as applicable.

• Ensure collaboration with teams in Pharmaceutical Development/ Technical Operations and Subject Matter Experts (SME) to deliver (coordination, authoring and review) effective, timely and compliant CTA (IND, IMPD) and MAA modules 1, 2 & 3 in the correct format “Ready For Submission” for Ipsen products portfolio in compliance with eCTD requirement and Ipsen Group Regulatory Affairs Dossier Management rules as required.
• Responsible for the CMC dossier generation process across all functions: ensure the role of each function involved in the generation of the CMC dossier is clear and will provide the right data with the correct level of detail in compliance with regulatory requirement.
• Manage timely and efficiently the Response to CMC questions from National Health Authorities worldwide with support from Pharmaceutical Development/ technical Operations teams and Subject Matter Experts (SMEs) as necessary to reach submission approval.
• Prepare and maintain the necessary CMC writing trackers, monitor progress and provide regular updates to the team.

• Participate and represent CMC regulatory strategy department in CMC project teams and Global project team, as necessary, for the assigned projects.
• Proactively provide Ipsen functions (e.g. Pharm Dev, TechOps, SMEs, GRA, Global project teams, etc) with CMC regulatory expertise.
• Communicate key regulatory CMC related guidance’s to Pharmaceutical Development/ technical Operations teams, SMEs and other stakeholders within Ipsen.
• Participate in the monitoring of the external environment to identify trends and assess potential impact on business and communicate this information to stakeholders.
• Actively participate in Industry associations or working groups and ensure company’s interests are taken into account.

• Coach and develop junior resource within the regulatory strategic CMC Group
• Lead and manage assigned projects and associated communication and reporting.
• Monitor and report on CMC Regulatory activities and process performance for the allocated products; identify areas for improvement, implement and monitor subsequent actions.

• Establish and maintain an excellent working relationship with Pharm Dev/ TechOps teams and the Ipsen regulatory community, in particular with Ipsen Global Regulatory Affairs Therapeutic Area Leads, European and intercontinental leads, Regulatory Operations Publishers and Ipsen affiliates/partners to ensure efficient coordination of regulatory submissions.
• lead contact with external Alliance partners and CMOs ensuring aligned strategy and optimised communication.
• Build effective relationships with global/regional regulators through agencies meetings, scientific advices and scientific workshops to ease validation on Ipsen strategy
• Actively contribute to the Regulatory Community life.

Knowledge & Experience

Knowledge & Experience (essential):

Knowledge & Experience (preferred):

Education / Certifications (essential):

Education / Certifications (preferred):

Language(s) (essential):

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